Eli Lilly’s clinical trial of its experimental COVID-19 antibody drug has been paused due to a safety concern, according to an email obtained by Brief19, a COVID-19-related medical research news site created by three physicians.
Eli Lilly confirmed the halt to The New York Times. The trial’s independent data safety monitoring board recommended a pause in enrollment for the trial, “out of an abundance of caution due to a potential safety concern,” the email states. No details have been released about the safety concern, but the email states more details will be released “in the next few hours.”
The email was sent Oct. 13.
It’s not uncommon for there to be halts in large clinical trials, the Times reported, and illness found in a participant is not necessarily tied to the experimental drug.
Eli Lilly submitted an emergency use authorization request with the FDA Oct. 7 for the antibody drug, saying clinical trials showed it may be effective in treating patients at risk for serious outcomes from COVID-19.
President Donald Trump received a similar antibody drug from Regeneron as part of his COVID-19 treatment. He and White House Chief of Staff Mark Meadows are both urging the FDA to quickly grant an emergency use authorization for Regeneron’s antibody drug as well as Eli Lilly’s.
Eli Lilly signed an agreement with the Bill and Melinda Gates Foundation Oct. 8 to supply the antibody drug to low- and middle-income countries.
Earlier the same day Eli Lilly halted its antibody drug trial, Johnson & Johnson paused its COVID-19 vaccine trial over a participant’s “unexplained illness.” Last month, AstraZeneca halted its vaccine trial after a participant fell ill. The trial has resumed in the U.K. and other countries but hasn’t resumed in the U.S.
More articles on pharmacy:
7 key uncertainties surrounding the COVID-19 vaccine race
3 more drugmakers recall metformin due to carcinogen
J&J pauses COVID-19 vaccine trial over participant’s ‘unexplained illness’
© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.